The statements in this section merely provide background information related to the present disclosure and may or may not constitute prior art.
During hysterectomy procedures, such as total laparoscopic hysterectomy (TLH) procedures, the uterus and cervix are removed, creating an approximately circular structure at end of the vaginal canal called the vaginal cuff. The closure of the remaining vaginal cuff can be one of the most challenging aspects of the procedure. It is also considered to be one of the barriers to adoption of laparoscopic surgery to those trained in open procedures.
Few devices exist to assist with closure of the vaginal cuff. The few devices that do exist relate to the suturing directly, such as Quill sutures, Covidien V Loc knotless, Ethicon Lapar Tys, and Covidien Autosuture Endostitch, by way of example. Typically, these devices do not include any assistance in the subsequent closure of the tissue to allow ease of closure and few include means to prevent escape of insufflations.
Surgeons typically use two techniques to close the cuff once they have introduced a seal against the internal walls of the vagina to reinstate insufflations in the pelvic cavity. Typically, a sponge filled glove is placed within the vaginal cavity to achieve a seal. This tends to move the often flaccid vaginal cuff into a rounder, more irregular shape.
The final closure of the cuff results in the flattening of the circular cuff opening into a flat line that is disposed transversely across the pelvis. To create the flat line, the cuff is sewn shut with sutures. Some surgeons begin suturing at one end of the eventual flat line, while others start in the middle of the final line and work to the ends. The advantage of starting at one end is reportedly that the pressure and skill required to bring the correct surfaces together are less than attempting to close in the middle. Conversely, closure in the middle allows for a more even spread of the sutures and possibly a more even distribution of sutures across the cuff closure line. While the vaginal cuff is being sutured closed, the peritoneal fold may mask the vaginal cuff opening. Furthermore, located directly above the cuff is the bladder, posing further challenges on the surgeon's skill in appropriately suturing and manipulating the suture needle without damaging the bladder.
Among the literature that can pertain to this technology include the following patent documents: U.S. Pat. No. 5,312,391; U.S. Pat. No. 5,318,013; U.S. Pat. No. 5,474,057; and U.S. Pat. No. 8,137,263, all incorporated by reference for all purposes.
Given the difficulties in correctly closing the vaginal cuff, there exists a need for tools and procedures that will aid surgeons in the process.